Recruiting
Phase 1

Centella Asiatica

Sponsor:

Oregon Health and Science University

Code:

NCT05591027

Conditions

Mild Cognitive Impairment

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Centella asiatica product

Placebo

Study Details

Brief summary:

This clinical trial is focused on determining whether biological signatures of target engagement by a Centella asiatica water extract product administered orally for 6 weeks can be measured in comparison to placebo. This study will also assess the safety and tolerability of the Centella asiatica water extract product.

Conditions

Mild Cognitive Impairment

Alzheimer's Disease

Study ID

NCT05591027

Start date

Dec 1, 2022

Status verified date

Apr, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Age 60-85, male and female
  • Sufficient English language skills to complete all tests
  • Sufficient vision and hearing to complete all tests
  • No known allergies to Centella asiatica
  • Absence of significant depression symptoms (Geriatric Depression Scale-15 score of < 5).
  • Total score of <2 on the suicidal ideation subscale (measures 3, 7, 11, 12 and 14) of the Geriatric Depression Scale.
  • Body Mass Index (BMI) greater than 17 and less than 35 at screening
  • General health status that will not interfere with the ability to complete the study
  • Willingness to discontinue all botanical dietary supplements for one week prior to and during the study.
  • Willingness to undertake multiple MRI scans
  • Meet the National Institute of Aging - Alzheimer's Association core clinical criteria for MCI or probable AD dementia with a Clinical Dementia Rating score of 0.5-1 and Mini Mental State Examination score of 20-28 at screening and baseline
  • Participants who report a history of participative memory decline with gradual onset and slow progression over the last one year before screening MUST be corroborated by an informant.
  • Participants on acetylcholinesterase inhibitor or memantine therapy for AD must be on a stable dose for at least 12 weeks prior to baseline visit.
  • Participants must have an identified caregiver/study partner that can accompany participant to all study visits.

Exclusion criteria:

  • Current smoking, alcohol, or substance abuse according to DSM-V criteria
  • Women who are pregnant, planning to become pregnant, or breastfeeding
  • Men who are actively trying to conceive a child or planning to within three months of study completion
  • Severe aversion to venipuncture
  • Abnormal labs indicating asymptomatic and untreated urinary tract infection
  • Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade < 3) and non-metastatic skin cancers
  • Comorbid conditions such as type I diabetes mellitus, poorly controlled type II diabetes mellitus (HbA1c > 7%), kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease
  • Significant disease of the Central Nervous System (CNS) such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
  • Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria
  • Medications: anti-epileptics, sedatives, amitriptyline, anticoagulants (e.g., warfarin), investigational drugs used within five half-lives of baseline visit, systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, narcotic analgesics, nicotine (tobacco, patches, gum, lozenges, etc.), Cannabis sativa (herb or edibles), beta blockers and anti-depressant medications that have not been at stable dosage for two months (including SSRIs, SNRIs)
  • Non-Alzheimer dementia such as vascular dementia, normal pressure hydrocephalus, or Parkinson's disease
  • MMSE score of < 20 or > 28
  • Unwilling to maintain stable dosage of AD medications throughout study duration
  • Unwilling to maintain stable dosage of intervention throughout the course of the study
  • Contraindications to Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) scans (some metal implants, pacemakers, claustrophobia)

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Centella asiatica water extract product (CAP) 4g

A sachet of containing 4g dried hot water extract (CAW) of Centella asiatica combined with inactive ingredients (excipients) will be dissolved in water and orally consumed daily as a drink for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.

placebo comparator: Placebo

A sachet of inactive ingredients (excipients) identical in composition to those found in the active arm will be be dissolved in water and orally consumed daily for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.

Interventions

Centella asiatica product

A sachet of powdered product containing 4 g of a dried hot water extract of Centella asiatica as the active ingredient, combined with inactive ingredients (excipients) for color and taste dissolved in 10 oz of warm or room temperature water and consumed orally.

Placebo

A sachet of powdered inactive ingredients (excipients) for color and taste identical in volume to those found in the active arm (CAP) dissolved in 10 oz of warm or room temperature water and consumed orally.

Primary outcome measure

  • Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention. [ Time Frame: Baseline and 6 weeks ]

Central Contacts and Locations

Central contacts

Amala Soumyanath, PhD

503-494-6878soumyana@ohsu.edu

Lucy Allison, MS

503-418-8197allisolu@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Amala Soumyanath, PhD

503-494-6878soumyana@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 11, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-04-11.